Specimen-taking device

ABSTRACT

A cylindrical tube has a retractable specimen gathering piece at one end thereof connected to a reciprocable activating member which extends out of the other end of the tube, the tube having a cylindrical cover into which the specimen gathering end thereof is inserted, the cover containing information identifying the person from whom the specimen is taken.

United States Patent [191 Zalucki 1 3,800,781 Apr.2,1974

[ SPEC lMEN-TAKING DEVICE [76] Inventor: Kazimierz Zalucki, 7 HolyokeSt.,

Easthampton, Mass. 01027 [22] Filed: May 30, 1972 [21] Appl. No.:257,595

[52] U.S. C1. 128/2 B, 128/2 W, 128/304 [51] Int. Cl A6lb 10/00 [58]Field of Search 128/2 W, 2 B, 2 R, 304, 128/262, 269, 263

[56] References Cited UNITED STATES PATENTS 5/1972 Moyle, Jr. et a1.128/2 B 11/1970 Ayre 128/2 B 3,086,527 4/1963 Forrest 128/2 W 2,835,2465/1958 Boettger 128/2 W 3,394,699 7/1968 Koett 128/2 B 3,592,186 7/1971Oster 128/2 B Y \0 22 3e 44 I2 McDonald 128/2 B 3,037,495 6/1962 Naz128/2 13 3,500,819 3/1970 Silvcrman.... 128/262 X 1,098,222 5/1914Brascficld [28/262 FOREIGN PATENTS OR APPLICATIONS 215,350 2/1908Germany 128/2 W Primary ExaminerKylc L. Howell Attorney, Agent, orFirm-Shlesinger, Arkwright, Garvey & Dinsmore [57] ABSTRACT Acylindrical tube has a retractable specimen gathering piece at one endthereof connected to a reciprocable activating member which extends outof the other.

end of the tube, the tube having a cylindrical cover into which thespecimen gathering end thereof is inserted, the cover containinginformation identifying the person from whom the specimen is taken.

9 Claims, 3 Drawing Figures 1 SPECIMEN-TAKING DEVICE BACKGROUND OFINVENTION This invention relates to specimen gathering devices forobtaining samples from inaccessible parts of body cavities.

It is the usual practice to employ trained medical personnel to obtainspecimens and cultures for analysis from body cavities, such as thevagina, rectum, nose, ears, mouth or throat. The care that must be takento obtain a specimen from the desired area of interest, precluding ofcontamination of the specimen taken, and minimizing of the chance ofinjury to delicate cavity areas, has required the use of trainedpersonnel.

Consequently, it has been necessary for individuals to make appointmentsand to appear at doctors offices or hospitals to have tests made. Thisrequirement entailed loss of time and considerable expense to theindividual, contributing toward a negligent and procrastinating attituderegarding many tests that should be taken at regular time intervals.

The present invention seeks to correct this situation while making itpossible for the individual to conveniently, safely, and correctlyobtain their own specimen or culture which can then be forwardeddirectly to the laboratory for analysis.

SUMMARY OF INVENTION Accordingly, this invention contemplates providinga specimen gathering device which can be safely usedby untrainedindividuals to obtain their own specimens which can then be sealed andforwarded to a laboratory for testing and evaluation.

The specimen taking device is designed so that it is self-contained, andcan be self-administered. The samples are sealed automatically toprevent contamination, and the device inserted within a container havingidentification data thereon. The entire assembly can then be mailed tothe laboratory.

The specimen taking device permits an individual to safely obtainspecimens from remote internal areas of DESCRIPTION OF THE DRAWINGS FIG.1 is a perspective view of the two main parts of the invention.

FIG. 2 is a sectional view of the assembled unit.

FIG. 3 is a partial section of the insertion tube with the probe inextended specimen gathering position.

DESCRIPTION OF THE INVENTION FIGS. 1 through 3 show the preferredembodiment of the instant invention. FIG. 1 shows the specimen-takingdevice generally indicated 10, in perspective, with the tubularcontainer or cover 12 removed. The container 12 has an identificationlabel 14, which provides space for the name and the date to be placedthereon, as well as an identification or serial number. It is possiblethat such a label could be used to provide complete data, including thereturn address of the individual submitting the specimen. This wouldpermit the laboratory to remove the label after the tests were completedand to affix it to a return envelope in which the results of the testson the specimens by the laboratory were to be mailed back to theindividual submitting the specimen.

The container 12 is of hollow construction and has an enclosed end 16and an open end 18 which fitsover and around the cylindrical insertiontube assembly 20.

FIG. 2 which is a sectional view of the assembled specimen-taking deviceshows in more detail the structural configurations of the device. Thecylindrical in-, v

sertion tube 20 has a rounded annular scraping edge 22, and an annularsealing surface 24 on the interior of the insertion tube 20 immediatelyadjacent to the annular scraping edge 22.- The other end of thecylindrical insertion tube 20 has a flanged annular seal construction 26having an annular negative sloped sealing lip 28.

FIG. 2 shows the assembled specimen-taking device as it would be soldand as it would be shipped after use to the laborabory for testing. Thespecimen gathering piece generally indicated at 30 isshown in FIG. 2 inthe retracted sealed position. It has an outer hemispherical probesection 32 and on the inner probe section is a reduced and taperedsample gathering section containing longitudinally extending ferrules34'which contact and gather specimens. The smooth inwardly taperingsection 36 of the insertion tube immediately behind the annular sealsurface 24 is integral with a continuous tapered and conical shapedelastic diaphragm 38 which cooperates to form one of the walls of theannular chamber 40 between them and the ferrule section 34 of thespecimen gathering member 30.

j The narrow neck section 42 of the specimen gathering member 30connects the ferrule section 34 of the probe to the central portion ofthe generally conically shaped diaphragm 38. The intermediate section 46is an integral part of the central and outer side of the flex-' iblediaphragm 38, as well as constituting the inner end of the operatingstem 48 which has a knurled surface 50 to give good gripping action andprevent slipping when the user forces the stem 48 either inwardly oroutwardly during the course of obtaining specimen material. 1

FIG. 3 shows the specimen gathering member in an, extended position,with the ferrules-34 exposed for obtaining sample material. It will benoted that the stem 48 has been pressed into the insertion tube 20 sothat the forward end section 46 presses against the flexible plasticdiaphragm 38 inverting it and permitting movement of the samplegathering member 30 outwardly from the rounded scraping edge 22 of theinsertion tube 20 to expose the ferrules 34. The outer portion of thediaphragm 52, as shown in FIG. 3 extends to a point approximately evenwith the annular sealing surface 24 at the end of insertion tube 20.After the area to bev sampled is engaged and the cultures taken, theknurled section 50 is grasped and the stem 48 pulled outwardly at theend adjacent the seal container interlock 26, retracting the specimengathering member 30 back into the tube and into the position shown inFIG. 2. The

specimen is contained within the sample holding chamber 40 in anairtight sealed configuration by the engagement of the outer peripheryof the hemispherical member 32with the sealing surface 24 of thecylindrical insertion tube 20.

The container 12 is then placed over the insertion tube assembly 20 andits end seal groove 54 passed over the negative sloping sealing lip 28of the seal con- OPERATION The invention is designed for use ingathering cells from the vaginal and cervical areas for cytologicevaluation, and is used for diagnosing in a manner similar to thecommonly used Papanicolaou Smear test.

However, the invention can be used to gather samples from other remoteportions of body cavities, such as the nose, ear and rectum. In each ofthese cases special adaptive configuration and sizes are assumed, butthe basic principles are the same.

The preferred embodiment forconstruction of the spherical probe 30 isthat of a low durometer reading rubber to permit insertion with theleast discomfort. However, it is also contemplated that for massproduction techniques, it would be desirable to use a suitably moldabletype of soft resilient plastic for the construction of these devices.

It should be noted that the outer end annular surface 22 of theinsertion tube 20 has rounded'edges to facilitate penetration andpreclude any injury to internal organs. The ferrules 34 will give ascraping action with a slight rotary motion, so as to induce cells andspecimen to accumulate thereon and possibly move back along the taperedsurface to the narrow neck portion 42, prior to retraction of thespecimen gathering member 30 to its initial position within the tube. I

The configuration of the diaphragm 38 is preferred, but it is understoodthat there may be some variation in this configuration to permit thehinging and moving action desired when the stem 48 is reciprocated.

The device, being designed for self-use in gathering specimen samplespermits the cover container 12 to be readily removed by pulling it freefrom the insertion tube 20. The insertion tube 20 has a smooth exteriorsurface, and for use, surgical jelly is preferably applied thereto toprovide lubrication when the insertion tube 20 is forced into the cavityand subsequently rotated.

pressed down into sealing engagement with the sealing flange section 26of the insertion tube as shown in FIG. 2 and described above. The label14 is then filled out and the entire assembly mailed to the laboratoryfor test and evaluation.

With regard to the identification system, it is also.

possible to provide a coded identification number for purposes ofidentification, so that the name of the person submitting the samplewould remain anonymous. In this instance the identification number wouldbe permanently imprinted or stencilled on the container tube.

It can readily be seen that the subject invention makes possible the useof a selt administered device which is of simple and cheap manufacture,permits the taking of samples in the privacy of ones home, andeliminates the need for trained medical personnel to take an accuratesample which can be sealed.

The parts themselves could be produced for substantially less than adollar, and the pans could be sterilized and sealed to precludeinfection.

While this invention has been described, it will be understood that itis capable of further modification, and this application is intended tocover any variations, uses and/or adaptations of the invention followingin general, the principle of the invention and including such departuresfrom the present disclosure as come within known or customary practicein the art to which the invention pertains, and as may be applied to theessential features hereinbefore set forth, as fall within the scope ofthe invention or the limits of the appended claims.

the forward end of the elongated tubular member and configured anddisposed so that it can be re-. tracted into the forward end of thetubular support member;

c. hinge means connected to the rear of the specimen gathering memberand to the inside of the tubular support member for permitting movementof the sampling member into and out of the forward end of the tubularsupport member,

d. an activating rod connected to the specimen gathering member at itsrearward end and extending through said tubular support member and outof the rear end of the tubular support member,

e. sealing means defined by the forward end of the tube and a portion ofthe sampling means for sealing the specimen taken by thespecimen-gathering member.

2. The device for obtaining specimens from internal areas of bodycavities as set forth in claim l, wherein:

a. a removable cylindrical cover member is disposed over the elongatedtubular support member covering the forward end thereof and being insealing engagement with the elongated tubular support member, b. labeland identification means is contained on the outer surface of the covermember. 3. The device for obtaining specimens from internal areas ofbody cavities as set forth in claim 2, wherein:

a. the label and identification means includes an area for a returnaddress which is removable from the cover member.

4. The device for obtaining specimens from internal areas of bodycavities as set forth in claim 1, wherein:

a. the specimen gathering member includes a forward hemisphericalsection, and a rearwardly tapering section which has specimen collectingmeans thereon.

6. The device for obtaining specimens from internal.

areas of body cavities as set forth in claim 5, wherein:

a. the specimen collecting means includes a plurality of longitudinallyextending ridges.

7. The device for obtaining specimens from internal areas of bodycavities as set forth in claim 1, wherein:

a. the seal means includes an annular sealing surface adjacent theforward end of the insertion tube which engages the periphery of thespecimen gathering member,

b. the specimen gathering member includes a forward hemisphericalportion which engages the annular sealing surface of the insertion tube,and

c. the specimen gathering member also includes a specimen gatheringsection at the rear of the hemispherical portion, and immediatelyadjacent the hinge means, on which specimen collecting means isdisposed.

8. The device for obtaining specimens'from internal areas of bodycavities as set forth in claim 1, wherein:

a. the hinge means is a flexible member and is integrally connected tothe junctureof the specimen gathering member and the activating rod.

9. The device for obtaining specimens from internal areas of bodycavities as set forth in claim 1, wherein:

a. the elongated tubular support membenthe specimen gathering member,the hinge member, and the activating rod are all one continuous unitarymolded plastic piece.

1. A device for obtaining specimens from internal areas of bodycavities, comprising: a. an elongated tubular support member, b. aspecimen gathering member disposed adjacent the forward end of theelongated tubular member and configured and disposed so that it can beretracted into the forward end of the tubular support member; c. hingemeans connected to the rear of the specimen gathering member and to theinside of the tubular support member for permitting movement of thesampling member into and out of the forward end of the tubular supportmember, d. an activating rod connected to the specimen gathering memberat its rearward end and extending through said tubular support memberand out of the rear end of the tubular support member, e. sealing meansdefined by the forward end of the tube and a portion of the samplingmeans for sealing the specimen taken by the specimen-gathering member.2. The device for obtaining specimens from internal areas of bodycavities as set forth in claim 1, wherein: a. a removable cylindricalcover member is disposed over the elongated tubular support membercovering the forward end thereof and being in sealing engagement withthe elongated tubular support member, b. label and identification meansis contained on the outer surface of the cover member.
 3. The device forobtaining specimens from internal areas of body cavities as set forth inclaim 2, wherein: a. the label and identification means includes an areafor a return address which is removable from the cover member.
 4. Thedevice for obtaining specimens from internal areas of body cavities asset forth in claim 1, wherein: a. the seal means includes an annularsealing surface adjacent the forward end of the insertion tube whichengages the periphery of the specimen gathering member.
 5. The devicefor obtaining specimens from internal areas of body cavities as setforth in claim 1, wherein: a. the specimen gathering member includes aforward hemispherical section, and a rearwardly tapering section whichhas specimen collecting means thereon.
 6. The device for obtainingspecimens from internal areas of body cavities as set forth in claim 5,wherein: a. the specimen collecting means includes a plurality oflongitudinally extending ridges.
 7. The device for obtaining specimensfrom internal areas of body cavities as set forth in claim 1, wherein:a. the seal means includes an annular sealing surface adjacent theforward end of the insertion tube which engages the periphery of thespecimen gathering member, b. the specimen gathering member includes aforward hemispherical portion which engages the annular sealing surfaceof the insertion tube, and c. the specimen gathering member alsoincludes a specimen gathering section at the rear of the hemisphericalportion, and immediately adjacent the hinge means, on which specimencollecting means is disposed.
 8. The device for obtaining specimens frominternal areas of body cavities as set forth in claim 1, wherein: a. thehinge means is a flexible member and is integrally connected to thejuncture of the specimen gathering member and the activating rod.
 9. Thedevice for obtaining specimens from internal areas of body cavities asset forth in claim 1, wherein: a. the elongated tubular support member,the specimen gathering member, the hinge member, and the activating rodare all one continuous unitary molded plastic piece.